Enforcement news

Recent prosecutions

Part of a shipment of unapproved injectable lignocaine,
destined for export to the Philippines,
seized by TGA investigators in Melbourne

Recent prosecutions by the Surveillance Unit have resulted in the convictions of:

• a Melbourne man in relation to the manufacture and export of dental lignocaine, an injectable anaesthetic;
• a Sydney man in relation to the import of traditional Chinese medicines;
• a Brisbane company in relation to the import of nonprescription drug products; and
• a Sydney company in relation to the import and supply of herbal ecstasy tablets.

"Export Only" listings of duty free stores

Products that are included in the Register (ARTG) as "export only" listings are approved for export from Australia only. These products are not approved for supply in Australia and any such supply may constitute a criminal offence.

Supply of these products, by a sponsor or manufacturer, to a duty free store in Australia; or by a duty free store to customers in Australia, constitutes a supply in Australia of those goods. In these circumstances the goods have not been exported and the suppliers may be liable in relation to the unlawful supply of the goods in Australia.

One of 212 cartons seized by TGA investigators in Sydney.
These cartons of household goods were used to smuggle a
large quantity of unapproved prescription and non-prescription
drugs into Australia. The drugs also included a number of
prohibited imports

Industry fraud

Australia's therapeutic goods industry enjoys a deserved reputation for the high quality of the product it produces and for the ethical standards under which it operates. As a general principal, the industry complies with the legislation and provides considerable cooperation to TGA investigations.

Fraudulent industry practices, such as substituting ingredients, switching labels to hide ingredients or extend expiry dates, and the production of documentation that misrepresents product ingredient, strength and dosage size have been detected during Surveillance Unit investigations.

The purpose of such schemes have generally been to enable unlawful product to be placed in the lawful market and are usually profit motivated. The damage such schemes can have on the reputation of the industry, particularly in Australia's pharmaceutical export markets, can be considerable.

The Surveillance Unit greatly appreciates the support of sponsors and manufacturers in combating fraudulent practices that have the potential to undermine the integrity of the industry.

Australian seahorses protected

A traditional Chinese medicine product seized by
TGA investigators that contains 10% seahorse (hippocampus).
This product was part of a large shipment of illegally imported
drug products and also contains seven other
internationally protected species as ingredients

Federal Environment Minister, Robert Hill has announced that from 1 January 1998, exports of all species of syngnathids (seahorses, seadragons and pipefishes) found in Australian waters will be stringently controlled.

"Half of the world's 220 known species of syngnathids occur in Australian waters and there is strong demand for their use in traditional Asian medicines," Senator Hill said.

"Populations of seahorses, seadragons and pipefishes have declined dramatically in many parts of the world through uncontrolled and excessive trade. The decision to protect these species is a precautionary measure by Australia, which acknowledges the worldwide concern over the exploitation of syngnathids," Senator Hill said.

There are currently no therapeutic goods included in the ARTG that contain any of these species. Sponsors are advised however, that should they wish to export any product in the future containing this material, in addition to TGA requirements, a permit will also be required from Environment Australia under the provisions of the Wildlife Protection (Regulation of Exports and Imports) act, 1982.

Environment Australia can be contacted in relation to permits.

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Customer service charter

This issue of TGA News includes a copy of the draft TGA Customer Service Charter which is designed to promote greater transparency and client-focus in TGA operations.

TGA has always prided itself on providing professional service of a high level. This Charter helps explain to customers and staff alike what to expect of TGA and the responsibilities of clients to help ensure a world class service.

When the Charter is finalised it will be circulated widely and evaluated over the next twelve months. Any feedback on this draft Charter is most welcome. Please direct any comments to:

TGA Customer Service Charter
GPO Box 100
Woden ACT 2606

The role of TGA Library in literature-based submissions

Information specialists from TGA Library have recently been involved in the development of new options for Literature Based Submissions (LBSs). The key change is the introduction of the Presubmission Meeting. This meeting provides an opportunity for TGA and industry to come to agreement on various aspects of a specific submission, including the design of an effective literature search.

The Presubmission Meeting and other aspects of the LBS process are outlined in a draft update points to consider document (Literature Based Submissions - Points to Consider, update draft 4, 22/9/97) which has recently been distributed to industry through the Australian Pharmaceutical Manufacturers Association.

The current role of TGA Library staff

TGA Library information specialists have a key role in advising Delegates from TGA's Drug Safety and Evaluation Branch (DSEB) on the adequacy of literature searches provided to TGA in support of Literature Based Submissions.

On the advice of the relevant Delegate in DSEB, TGA Library staff review the literature search provided in support of a LBS. This review is to investigate whether the relevant literature has been identified for the purposes of the submission. It involves a perusal of all aspects of the search conducted to support the LBS, including the selection of databases and the design of the search strategy used in identifying literature.

Library information specialists perform these tasks with advice from the Delegate on the relevant issues to be pursued with regard to the quality, safety and efficacy of the drug in question for the indication identified in the submission.

The information specialist performing the LBS investigation writes a report to the Delegate covering the nature and adequacy of the literature search. The delegate uses this report in coming to a decision on the submission.

The presubmission meeting option

The Presubmission Meeting is a new option which is expected to assist in the compilation of a LBS.

Sponsors should submit their draft literature search well before the Presubmission Meeting. This will allow TGA Library information specialists to investigate relevant databases, indexing, strategies and other issues related to the product under evaluation prior to the Presubmission Meeting.

At the Presubmission Meeting, it is envisaged that a TGA Library information specialist will assist the Delegate and sponsor to come to an agreement on a literature search which is acceptable to TGA. For this to occur, the sponsor should come prepared to discuss the literature search and bring the strategist involved in the design of the search to the meeting.

Given an agreement on the literature search, providing this search is carried out as agreed and within reasonable time limits, the sponsor can be confident that the expenditure of further time and energy on the submission will not be lost through rejection of the literature search.

Strategic information planning project - information systems to improve TGA performance and client access

In the six years since TGA was established, we have come a long way in the use of Information Technology (IT). In the early years, the TGA had to develop IT systems quickly in order to meet the immediate information needs of the time. Generally this meant delaying the development of communication links between the various systems and the management information reporting capability. While these systems have served us well and enhancements have been made over the years, it is time to reassess whether they are adequate in today's environment.

Advances in technology and new business methods demand that we look closely at the way we do business. The Strategic Information Planning Project (SIPP) has been established to look particularly at the way we manage information and use technology to support our business practices. This includes looking at ways to increase the use and effectiveness of electronic transmission of data between the TGA and its various clients and stakeholders.

The SIPP project began in August. Phase 1 of the project - the mapping of our current environment, involved documenting the flow of information within the TGA and identifying all formal and informal internal electronic and paper information systems. This phase of the project is complete.

Phase 2 - identification of strategic information requirements, has begun. As part of the consultation process we have sought the views of industry representatives in the Australian Pharmaceutical Manufacturers Association (APMA), the Proprietary Medicines Association of Australia (PMAA), the Medical Industry Association of Australia (MIAA), the Nutritional Foods Association of Australia (NFAA) and the Cosmetic Toiletry and Fragrance Association of Australia (CTFAA) on ways we can improve sponsor access to information.

The project team would like to acknowledge the cooperation and positive contributions made by both the staff of the TGA and the industry representatives with whom we have spoken to date. As the project continues, this wider consultation will continue and we will keep you informed of progress by regular bulletins in future editions of the TGA News.